abt-510 in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: abt-510 may stop the growth of melanoma by blocking blood flow to the tumor. purpose: this phase ii trial is studying how well giving abt-510 works in treating patients with metastatic melanoma.

objectives: * examine the safety profile of abt-510 in patients with metastatic malignant melanoma. * examine the antitumor activity (i.e., time to progression and response rates) in patients treated with abt-510. * determine the pharmacodynamic effects of abt-510 and its potential impact on immune cell function in these patients. outline: patients receive abt-510 subcutaneously twice daily on days 1-21. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. blood samples are obtained at baseline, before treatment on day 1 of cycles 2 and 3, and then every other course thereafter for pharmacological and ancillary studies. samples are evaluated for ec enumeration, expression profiling, circulating tumor cell quantification, analysis of t-cell functions (i.e., immunophenotyping for nk-, t- and b-cell phenotypes as well as elispot analysis against common environmental pathogens and t cell spectratyping), and angiogenesis bioassays. patients also undergo ultrasound-guided core tumor biopsies for histological analysis of microvascular density (cd38 and von willebrand factor immunohistochemistry) at baseline and before treatment on day 1 of courses 3 and 5. after completion of study treatment, patients are followed every 3 months for up to 5 years.

Eligibility criteria:
disease characteristics: * histologically confirmed malignant melanoma * stage iv disease * no known potentially curative standard therapy that exists or is proven capable of extending life expectancy * measurable disease * no history of or current cns metastases * mri of the brain to confirm absence of cns metastases within the past 28 days is required * no known, presently active carcinomatous meningitis patient characteristics: * ecog performance status 0-2 * life expectancy ≥ 6 months * anc ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * alkaline phosphatase ≤ 3 times upper limit of normal (uln) * ast ≤ 3 times uln * creatinine ≤ 2.5 times uln * hemoglobin ≥ 9.0 g/dl * prothrombin time normal * willing to return to mayo clinic rochester, jacksonville or scottsdale for follow-up * must be able to self-administer or has a caregiver who can reliably administer subcutaneous injections * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no uncontrolled or current infection * no new york heart association class iii-iv heart disease * no recent history of (i.e., ≤ 12 weeks from study day 1) or current cancer-related bleeding event (e.g., hemoptysis) * no recent history of (within the past 4 weeks) or current noncancer-related clinically significant bleeding event * no uncontrolled hypertension * no history of stroke or other cns bleeding events (e.g., aneurysms) prior concurrent therapy: * at least 4 weeks since prior chemotherapy and recovered (6 weeks for mitomycin c or nitrosoureas) * at least 4 weeks since prior immunotherapy, biologic therapy, radiotherapy, or surgery * no concurrent anticoagulation therapy or antiplatelet therapy * no other concurrent antineoplastic agents (e.g., cytotoxic chemotherapy, immunotherapy, radiotherapy, or investigational therapy) except local radiotherapy for supportive reasons involving a small radiation field

Keywords: stage iv melanoma